FDA Adverse Event
Malfunction
Summary report: N
BARD ACCESS SYSTEMS, INC.
MDR report key: 309643
·
Received December 20, 2000
Report
- Report Number
- 309643
- Event Type
- Malfunction
- Date Received
- December 20, 2000
- Date of Event
- October 10, 2000
- Report Date
- November 4, 2000
- Manufacturer
- BARD ACCESS SYSTEMS, INC.
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE MEASURING A PICC LINE FOLLOWING REMOVAL THE CATHETER BROKE NEAR THE HUB. THERE WAS NOT EXCESSIVE PULLING UTILIZED WHEN IT BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD ACCESS SYSTEMS, INC. | PERQCATH (PICC LINE) | DQO | BARD ACCESS SYSTEMS, INC. | UNK | 22EK 2584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |